SAFETY
CIBINQO was studied in > 2850 patients with moderate-to-severe atopic dermatitis (AD)1,2
Laboratory monitoring and screening for patients taking CIBINQO
Monitoring
Hemoglobin
  • Do not initiate CIBINQO if Hgb <8 g/dL
Opportunistic Infections:
  • If a patient develops a serious infection, sepsis, or opportunistic infection, consider ;interruption of CIBINQO until the infection is controlled
Vaccines:
  • Use of live, attenuated vaccines during or immediately prior to CIBINQO therapy is not recommended. It is recommended that patients be brought up to date with all immunizations, including prophylactic herpes zoster vaccinations, in agreement with current immunization guidelines
Tuberculosis:
  • CIBINQO should not be given to patients with active TB. Prior to starting CIBINQO, perform a test for latent TB. For patients with a new diagnosis of latent TB or prior untreated latent TB, start preventative treatment prior to starting CIBINQO. Consider yearly screening for patients in highly endemic areas for TB. Monitor all patients for active tuberculosis during treatment, even if the initial latent tuberculosis test is negative
ALC=absolute lymphocyte count; ANC=absolute neutrophil count; Hgb=hemoglobin; TB=tuberculosis.
​​​​​​​Lab Abnormalities
Thrombocytopenia
  • In placebo-controlled studies, for up to 16 weeks, treatment with CIBINQO was associated with a dose-related decrease in platelet count
  • One patient (0.1%) in the CIBINQO 200 mg group met the discontinuation criteria for thrombocytopenia (platelet count 50 × 103/mm3). No patients in the 100 mg group or the placebo group met discontinuation criteria
  • Maximum effects on platelets were observed within 4 weeks, after which the platelet count returned toward baseline despite continued therapy
  • Among all patients exposed to CIBINQO, including the long-term extension study, confirmed platelet counts of &lt;50 × 103/mm3 were reported in 2 patients (0.1%), both treated with CIBINQO 200 mg
Lymphopenia
  • In placebo-controlled studies, for up to 16 weeks, confirmed ALC &lt;0.5 × 103/mm3 occurred in 2 patients (0.3%) treated with CIBINQO 200 mg and 0 patients treated with CIBINQO 100 mg or placebo
  • Both cases occurred in the first 4 weeks of exposure
Lipid elevations
  •  
  • In placebo-controlled studies, for up to 16 weeks, there was a dose-related percent increase in low-density lipoprotein cholesterol (LDL-c), total cholesterol, and high-density lipoprotein cholesterol (HDL-c) relative to placebo at week 4, which remained elevated through the final visit in the treatment period
  • There was no change in the LDL/HDL ratio or triglycerides
  • Events related to hyperlipidemia occurred in 1 patient (0.2%) exposed to CIBINQO 100 mg, 7 patients (1.2%) exposed to CIBINQO 200 mg, and 0 patients exposed to placebo
  •  
Creatine phosphokinase (CPK)
  •  
  • In placebo-controlled studies, for up to 16 weeks, events of blood CPK increased were reported in 1.5% of patients treated with placebo, 2.3% and 2.9% of patients treated with 100 mg and 200 mg of CIBINQO, respectively
  • Most elevations were transient, and none led to discontinuation. In the clinical studies, there were no reported events of rhabdomyolysis
  • In placebo-controlled studies, there was a dose-related increase in CK beginning at week 4, which plateaued at week 8
  • A dose-related increase also occurred in the proportion of subjects crossing a threshold of 2x ULN. However, CIBINQO groups did not have a higher proportion of subjects crossing thresholds of 5x and 10x/ULN
  • In the long-term extension study, CK remained increased throughout the study period. 5.4% of CIBINQO-treated subjects had CK levels >5x ULN
  •  
References: 1. CIBINQO™ (abrocitinib) Full Prescribing Information. April 2021. 2. Data on file. Pfizer Inc; New York, NY.
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